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Apixaban vs Warfarin in Peritoneal Dialysis Patients with Atrial Fibrillation
NCT06045858Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2024
- Primary completion
- Oct 2027
- Sponsor
- CHU Caen Normandie
- Modality
- Small Molecules
- Drugs
- apixaban
- Conditions
- Atrial fibrillation (AFib)
01
Overview
Phase 3, randomised, open-label trial of apixaban in Atrial fibrillation (AFib) (2 arms), sponsored by CHU Caen Normandie. Primary endpoint: Major or clinically relevant non-major bleeding at 12 months. Planned start Oct 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Apixaban Arm
Apixaban 2.5mg twice daily
Warfarin Arm
Warfarin dose-adjusted to INR target
03
Who it enrols
Adult patients with ESRD on peritoneal dialysis for at least 3 months and non-valvular atrial fibrillation (CHA2DS2-VASc >= 2). Excludes patients with recent stroke/TIA, severe hepatic impairment, or contraindications to anticoagulation.
04
Endpoints
Primary
Major or clinically relevant non-major bleeding
Secondary
Composite efficacy criterion
Time within INR target range
AntiXa apixaban activity
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